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Randomized Controlled Trial
. 2022 Aug;31(8):2519-2534.
doi: 10.1007/s11136-022-03106-1. Epub 2022 Mar 1.

Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia

N Samartin-Veiga  1 , A J González-Villar  2 , M Pidal-Miranda  3 , A Vázquez-Millán  3 , M T Carrillo-de-la-Peña  3
Affiliations
Randomized Controlled Trial

Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia

N Samartin-Veiga et al. Qual Life Res. 2022 Aug.

Erratum in

Abstract

Purpose: Fibromyalgia (FM) is a chronic pain syndrome with a strong impact on quality of life (QoL). Treatment of this condition remains a challenge, due to the scarce evidence for the effectiveness of the therapeutic approaches available. Current attention is focused on transcranial direct current stimulation (tDCS), which has yielded promising results for pain treatment. Rather than focusing only on pain relief, in this study, we aimed to determine how active or sham tDCS (over three cortical targets -the primary motor cortex, the dorsolateral prefrontal cortex and the operculo-insular cortex-) affect QoL in patients with FM.

Methods: Using a double-blind, placebo-controlled design, we applied fifteen tDCS sessions of 20' to initial 130 participants (randomized to any of the four treatment groups). We evaluated the QoL (assessed by SF-36) and the symptoms' impact (assessed by FIQ-R) in baseline, after treatment and at 6 months follow-up.

Results: All groups were comparable as regards age, medication pattern and severity of symptoms before the treatment. We found that QoL and symptoms' impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months. However, we did not observe any group effect nor group*treatment interaction.

Conclusions: After the intervention, we observed a non-specific effect that may be due to placebo, favoured by the expectations of tDCS efficacy and psychosocial variables inherent to the intervention (daily relationship with therapists and other patients in the clinic). Therefore, active tDCS is not superior to sham stimulation in improving QoL in FM.

Keywords: FIQ-R; Fibromyalgia; Quality of life (QoL); Randomized controlled trial (RCT); SF-36; Transcranial direct current stimulation (tDCS).

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Conflict of interest statement

The authors state that they do not have any competing interests.

Figures

Fig. 1
Fig. 1
Overview of the study design at different time points (pre-treatment, treatment, post-treatment, and follow-up)
Fig. 2
Fig. 2
Flow diagram showing the number of participants and randomization (CONSORT model; 2010)
Fig. 3
Fig. 3
Comparison of pre-, post- and follow-up treatment assessment of the eight SF-36 subscales for the different tDCS stimulation groups (M1, DLPFC, OIC and Sham). Higher scores indicate improvement in QoL
Fig. 4
Fig. 4
Comparison of pre-, post- and follow-up treatment assessment of the FIQ-R sub-scales for the different tDCS stimulation groups (M1, DLPFC, OIC and Sham). Lower scores represent improvement (i. e., decrease in symptom severity, impact, or functioning) in FM patients
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